HPTLC DETERMINATION OF SORAFENIB TOSYLATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Abstract

A simple and sensitive HPTLC method has been developed for the quantitative estimation of Sorafenib Tosylate in bulk and Pharmaceutical dosage form. Sorafenib Tosylate was chromatographed on silica Gel 60 F254 TLC plate using n-Hexane : isopropanol (8:2 v/v) as mobile phase. Sorafenib Tosylate showed Rf value 0.34±0.05 and scanned at 254 nm using Camag TLC Scanner 3. The method was validated in terms of linearity (100–500 ng/spot), precision (intra- day % RSD variation 0.07 to 0.39%, inter-day % RSD variation 0.5 to 1.2%), accuracy (98.88 to 100.815%) specificity, ruggedness, sensitivity and reproducibility. The limit of detection and limit of quantitation for Sorafenib Tosylate were found to be 1.57 ng/spot and 4.75 ng/spot, respectively. The developed method was successfully used for the assay of Sorafenib Tosylate in bulk and Pharmaceutical dosage form.. it can be used for the routine quality control testing of marketed formulations.